510(k) Report

510(k) · Cleared

Cleared

Genicon Suction Irrigation System

K041967510(k) AbbreviatedCleared Nov 12, 2004114-day reviewClass II21 CFR 876.1500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Genicon · GCJ Laparoscope, General & Plastic Surgery

Cleared on Nov 12, 2004 as substantially equivalent to K963646 (Stryker Endoscopy, 1997) after a 114-day review. Its family tree reaches back 1 generation to 1997. 9 later devices descend from it.

Decided
Nov 12, 2004
Review
114 days
Class
Class II
Product code
GCJ
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K963646 (1997). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2014: 1 descendant cleared2019: 1 descendant cleared2015: 1 descendant cleared2024: 1 descendant cleared2017: 1 descendant cleared2025: 1 descendant cleared2022: 1 descendant cleared2023: 1 descendant clearedK963646 · Stryker Strykeflow Suction Irrigator Gravity Flow · Stryker Endoscopy · 1997 · recalled1995200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K963646 · Stryker Strykeflow Suction Irrigator Gravity Flow · Stryker Endoscopy · 1997 · recalled0
  1. Root · 1 generation backK963646 Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy · 1997 · Recalled
  2. This deviceK041967 Genicon Suction Irrigation SystemGenicon · 2004
  3. Descendant · cites it directly · 8 of its ownK103509 Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011
  4. Descendant · 2 generations on · 2 of its ownK192643 Dannik Laparoscopic Suction Irrigation SystemDannik · 2019
  5. Descendant · 2 generations on · 2 of its ownK141592 Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014
  6. Descendant · 3 generations on · 1 of its ownK222575 HurriChem Device KitThermasolutions, LLC · 2022
  7. Descendant · 2 generations on · 1 of its ownK150253 Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation…Taiwan Surgical Corporation · 2015

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2011: 12014: 12015: 12017: 12019: 12022: 12023: 12024: 12025: 1
2011high 1 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 9 · See all
  • K103509Unimax Suction Irrigation SetUnimax Medical Systems, Inc. · 2011 · cites it directly8descendants
  • K192643Dannik Laparoscopic Suction Irrigation SystemDannik · 2019 · 2 generations on2descendants
  • K141592Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd. · 2014 · 2 generations on2descendants
  • K222575HurriChem Device KitThermasolutions, LLC · 2022 · 3 generations on1descendant
  • K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmTaiwan Surgical Corporation · 2015 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K963646Stryker Strykeflow Suction Irrigator Gravity FlowStryker Endoscopy19972
0 (this device)K041967Genicon Suction Irrigation SystemGenicon2004—
+1K103509Unimax Suction Irrigation SetUnimax Medical Systems, Inc.2011—
+2K192643Dannik Laparoscopic Suction Irrigation SystemDannik2019—
+2K141592Unimicro Suction Irriation Tubing SetUnimicro Medical Systems (Shenzhen) Co., Ltd.2014—
+3K222575HurriChem Device KitThermasolutions, LLC2022—
+2K150253Disposable Suction Irrigation, 330mm, Disposable Suction Irrigation, 450mmTaiwan Surgical Corporation2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201410
201510
201710
201910
202210
202310
202410
202510
FIG. 1 — Lineage of K041967, 1997–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GCJ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GCJ device

  1. #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K963646Stryker Strykeflow Suction Irrigator Gravity Flow
Summary page 1
…Irrigation Trade Name - Genicon Laparoscopic Suction Common Name - Suction Irrigation Classification - Class II- CFR 878.4400 Predicate Device - Stryker (K963646) Suction Irrigator Product Description - The Genicon Laparoscopic…
Stryker Endoscopy19972

Also cleared against K963646: 1 other device →

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103509Unimax Suction Irrigation SetUnimax Medical Systems, Inc.20118

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has a recall.
  • Of its descendants, K103509 (Unimax Medical Systems, Inc., 2011) has gone furthest, with 8 descendants of its own.
  • 1 other device also cites its predicate K963646.

How does its category compare?

All GCJ devices

GCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCJ

21in 2025

2007: 182008: 192009: 212010: 242011: 152012: 172013: 152014: 192015: 262016: 272017: 202018: 212019: 152020: 282021: 182022: 202023: 312024: 292025: 212026 (partial year): 26
2007high 31 (2023) · low 15 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GCJ

108in 2025

2007: 42 days median2008: 73 days median2009: 85 days median2010: 122 days median2011: 113 days median2012: 88 days median2013: 93 days median2014: 90 days median2015: 76 days median2016: 99 days median2017: 77 days median2018: 88 days median2019: 60 days median2020: 61 days median2021: 116 days median2022: 103 days median2023: 109 days median2024: 90 days median2025: 108 days median2026 (partial year): 122 days median
2007high 122 (2010) · low 42 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GCJ

5in 2025

2007: 122008: 162009: 62010: 302011: 92012: 12013: 7, 1 Class I2014: 22016: 52017: 12018: 12022: 12023: 12025: 52026 (partial year): 1
2007high 30 (2010) · low 0 (2015)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GCJ

5,860in 2025

2007: 1,6392008: 1,3192009: 1,9952010: 2,6572011: 2,1332012: 1,5262013: 1,5652014: 1,7142015: 1,7102016: 2,0802017: 3,4682018: 2,5622019: 2,5782020: 2,6182021: 3,4312022: 3,9452023: 6,0022024: 6,0472025: 5,860
2007high 6,047 (2024) · low 1,319 (2008)2025

MAUDE reports naming product code GCJ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071842121,639
20081973161,319
2009218561,995
201024122302,657
20111511392,133
2012178811,526
201315937 (1)1,565
2014199021,714
2015267601,710
2016279952,080
2017207713,468
2018218812,562
2019156002,578
2020286102,618
20211811603,431
20222010313,945
20233110916,002
2024299006,047
20252110855,860
2026261221—

What is it indicated for?

The GeniCon Laparoscopic Suction/Irrigation System is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic gynecologic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

Indications for use as stated in the FDA summary.

Also cleared against K963646

1 other device cites the same predicate.

  • K991323Smith & Nephew Subcutaneous IlluminatorSmith & Nephew, Inc. · 1999

More from Genicon

5 FDA decisions under this applicant name. See the company

  • K132375Genistrong Single-Use Specimen Retrieval BagGenicon · 20141 recall
  • K100090Implantable ClipGenicon · 2010
  • K061417Genicon Disposable Electrosurgical Instrumentation, Model 533-005-910Genicon · 2006
  • K041968Genicon Bipolar Forceps Model # 600-005-005Genicon · 2004

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The GCJ category page

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https://510kreport.com/device/K041967 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041967: Genicon Suction Irrigation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041967

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026